Which one is more important? The Kyprolis approval. It isn't even close.
Kyprolis represents the first drug that Onyx owns fully -- it shares profits on Nexavar with its partner Bayer (OTC: BAYRY). The approval isn't all that surprising given the 11-0 FDA advisory committee endorsement of Kyprolis and how the agency supported the drug during the meeting. But there are approval issues not discussed in an advisory committee meeting, like manufacturing, which can derail a drug, so the approval is never a sure thing.
Kyprolis will be used after other therapies -- Celgene's
Switching gears, the Nexavar clinical trial tested the drug in combination with Tarceva, compared to Nexavar alone in liver cancer patients. Interestingly, even though this trial seems like it was designed to expand Tarceva into liver cancer, Tarceva isn't sold by Onyx or Bayer. The Nexavar owners would benefit indirectly if the trial had worked because the combination product would set a new higher standard that new drugs would have to reach.
With the failure of Bristol-Myers Squibb's
With a new drug approved and a fairly meaningless clinical trial completed, investors can get back to speculating when Onyx will be taken out by Bayer.
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